A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use

NCT ID: NCT00784641

Last Updated: 2020-10-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

567 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-01-31

Brief Summary

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Evaluation of the clinical performance of a novel Bausch \& Lomb daily disposable contact lens when compared to the currently marketed Bausch \& Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Novel Bausch & Lomb Contact Lens

Novel Bausch \& Lomb daily disposable contact lenses

Group Type EXPERIMENTAL

Novel Bausch & Lomb daily disposable contact lenses

Intervention Type DEVICE

Lenses to be worn and replaced daily for 2 weeks.

SofLens

Bausch \& Lomb SofLens daily disposable contact lenses

Group Type ACTIVE_COMPARATOR

Bausch & Lomb SofLens daily disposable contact lenses.

Intervention Type DEVICE

Lenses to be worn and replaced daily for 2 weeks.

Acuvue

Johnson and Johnson 1-Day Acuvue Moist contact lenses

Group Type ACTIVE_COMPARATOR

Johnson and Johnson 1-Day Acuvue Moist contact lenses

Intervention Type DEVICE

Lenses to be worn and replaced daily for 2 weeks.

Interventions

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Novel Bausch & Lomb daily disposable contact lenses

Lenses to be worn and replaced daily for 2 weeks.

Intervention Type DEVICE

Bausch & Lomb SofLens daily disposable contact lenses.

Lenses to be worn and replaced daily for 2 weeks.

Intervention Type DEVICE

Johnson and Johnson 1-Day Acuvue Moist contact lenses

Lenses to be worn and replaced daily for 2 weeks.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye.
* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be myopic and require lens correction in both eyes.

Exclusion Criteria

* Subjects with any systemic disease affecting ocular health.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects wearing monovision, multifocal or toric contact lenses.
* Subjects with grade 2 or greater slit lamp findings.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bev Barna

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Dr. James Ferrari

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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496

Identifier Type: -

Identifier Source: org_study_id

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